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510(k) Data Aggregation

    K Number
    K253161

    Validate with FDA (Live)

    Device Name
    Balanced Knee System TriMax Porous Femoral Components
    Manufacturer
    Ortho Development Corp.
    Date Cleared
    2025-12-19

    (84 days)

    Product Code
    MBH
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K123457,K150680,K152169
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications:

    1. Loss of joint configuration and joint function.
    2. Osteoarthritis of the knee joint.
    3. Rheumatoid arthritis of the knee joint.
    4. Post-traumatic arthritis of the knee joint.
    5. Valgus, varus, or flexion deformities of the knee joint.
    6. Revision procedures where other treatments or devices have failed.
    Device Description

    Balanced Knee® System TriMax® Porous Femoral Components are intended for use as part of total knee arthroplasty (TKA) procedures. Total knee arthroplasty is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.

    The components are prescription products consisting of single use devices for implanting into patients in an operating room by a qualified surgeon.

    Balanced Knee® System TriMax® Porous Femoral Components are a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component with Co-Cr-Mo sintered porous coating.

    The device will have two configurations:

    • Cruciate Retaining (CR) Femoral – (Substantially Equivalent to K152169)
    • Posterior Stabilized (PS) Femoral – (Substantially Equivalent to K123457)

    They have the same materials of constructions and the same articular geometry as the legally marketed TriMax cemented femoral components. The new feature is the addition of the CoCr porous coating on the bone contacting surfaces that is substantially equivalent to the reference device: Maxx Orthopedics Freedom Porous Femoral Component (K150680).

    Balanced Knee® System TriMax® Porous Femoral Components are manufactured from cast Co-Cr-Mo per ASTM F75.

    The subject device has a variety of sizes to accommodate variations in patient anatomies: left and right orientations, medial-lateral width (56 – 79.5mm), anterior-posterior width (50 – 74mm), and CR & PS variations.

    Balanced Knee® System TriMax® Porous Femoral Components are compatible with BKS® High Flex PS Tibial Inserts (K123457, K131337), BKS® High Flex Patellar Button (K131337), BKS® TriMax® CR and US Tibial Inserts (K152169), and BKS® TriMax® PS Plus Tibial Inserts (K233093).

    AI/ML Overview

    N/A

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